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In brief

On 29 December 2021, the new Royal Decree 1157/2021 of 28 December, regulating industrially manufactured veterinary medicinal products (“Royal Decree 1157/2021“), was published in the Official State Gazette. This regulation replaces the existing Royal Decree 1246/2008 of 18 July 2008, regulating the procedure for the authorization, registration and pharmacovigilance of industrially manufactured veterinary medicinal products and also complements Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (“Regulation 2019/6“). Both Regulation 2019/6 and Royal Decree 1157/2021 will enter into force on 28 January 2022.

In more detail

The main changes introduced by Royal Decree 1157/2021 can be summarized as follows: 

  • Simplified registration, maintenance on the market and advertising. Royal Decree 1157/2021 includes simplified registration, which extends beyond homeopathic medicines to medicinal products intended for certain species of animals kept exclusively as pets. From an advertising standpoint, it establishes that the distribution of samples requires a prior authorization from the Spanish Agency of Medicinal Products and Medical Devices (AEMPS), and it is only permitted during the first year after the medicinal product is placed on the market, and for a maximum of five samples per veterinarian and a total of 200 samples.
  • Authorization procedure. Royal Decree 1157/2021 establishes the obligation for individuals to carry out administrative procedures by electronic means.
  • Labeling. Chapter III deals with labeling and the package leaflet, with particular attention on the guarantees of identification and information of the medicinal product, including those aspects that Regulation 2019/6 allows member states to regulate, such as accessibility for blind or partially sighted people. In this context, Royal Decree 1157/2021 sets out the obligation of the marketing authorization or registration holder to ensure that, in the case of medicines for pet animals, the package leaflet is available in appropriate formats for blind or partially sighted people.
  • Pharmacovigilance. Veterinarians, doctors, pharmacists and other healthcare professionals are obliged to report any suspected adverse event to the AEMPS or to the marketing authorization or registration holder of the medicinal product, within a maximum period of 15 days. Royal Decree 1157/2021 also sets out a new obligation to retain clinical documentation of suspected adverse drug events for a minimum period of five years. 
  • Suspension, revocation and variation of the terms of the marketing authorization or registration. Chapter VII deals with cases of suspension, revocation and variation of the terms of the marketing authorization or registration and the withdrawal of the marketing authorization or registration. It introduces a specific procedure for the variations and the change of the marketing authorization holder. 
  • Parallel trade. A new Chapter VIII is devoted to parallel trade, establishing for the first time a specific procedure for veterinary medicinal products, laying down the authorization procedure to be followed before the AEMPS and the obligations incumbent on the wholesale distributor.
  • Clinical research. The regulation is completed by Chapter IX on clinical research, which is divided into investigations with veterinary clinical investigational medicinal products, clinical trials with veterinary medicinal products and post-authorization studies, with the aim of including in a single regulatory document regarding veterinary medicinal products in line with the contents of Regulation 2019/6. Investigational medicinal products and veterinary clinical trials were already included in Royal Decree 109/1995 of 27 January 1995 and its subsequent development by Order PRE/2938/2004 of 7 September 2004, regarding the qualification of products in the clinical research phase and the conduct of clinical trials with veterinary medicinal products, which are repealed by Royal Decree 1157/2021.

Montserrat Llopart is a Partner in the International Commercial & Trade department and leads the Compliance and Healthcare Law practices in the Barcelona office. Her practice focuses on advising clients on regulatory, compliance, commercial contracts, consumer and acquisitions issues. She is a regular speaker and contributor to specialist conferences and publications and she is recognized by the leading legal directories as Chamber, Legal 500 and Best Lawyers and as InspiraLaw Top 50 Women List for Spain and Portugal. Montserrat headed the Barcelona office and the Firm's pharmaceutical law group in the EMEA region.

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